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NCT Number: NCT07004907

Efficacy and Tolerability of the APD Treatment in PAED Patients

The Silencia PD (peritoneal dialysis) cycler offers a pediatric (PAED) mode with advanced features such as Time and Volume Optimization (TAVO), supporting precise and individualized treatment. This study evaluates the efficacy and tolerability of Automated Peritoneal Dialysis (APD) using the Silencia PD cycler in patients weighing ≤ 20 kg and able to tolerate a minimum inflow volume of 100 mL. The primary objective is to determine whether patients achieve a total weekly Kt/Vurea ≥ 1.8.

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Key information

Conditions

Renal Failure Acute Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

0 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent signed and dated by legal representative and investigator/authorized physician
  • The minors have received the information referred to in Article 63(2) MDR in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children
  • The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
  • patients with renal failure treated or planned to be treated with APD
  • Body weight ≤ 20 kg
  • Ability to understand the nature and requirements of the study

Exclusion criteria

  • Any conditions which could interfere with the patient's ability to comply with the study
  • Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
  • Participation in an interventional clinical study during the preceding 30 days
  • Previous participation in the same study
  • Life expectancy < 3 months
  • Patients who suffer from peritonitis/exit site infection during the last 4 weeks

Treatment and study plan

Treatment with the pedriatic mode of the APD cycler

Device

Patients weighing less than 20 kg will be treated for 4 weeks with APD using the PAED mode of the Silencia PD cycler

Primary outcomes

  1. Total weekly Kt/V urea

    Time frame: The primary endpoint is total Kt/Vurea at week 2 and 4

    The primary objective is to determine whether patients achieve a total weekly Kt/V urea ≥ 1.8.

Secondary outcomes

  1. Mean daily ultrafiltration (UF)

    Time frame: Mean UF will be measured at weeks 2 and 4

  2. Residual renal function (RRF)

    Time frame: RRF will be measured at weeks 2 and 4

    Renal urea clearance

  3. Residual renal function (RRF)

    Time frame: RRF will be measured at weeks 2 and 4

    Renal creatinine clearance

  4. Residual renal function (RRF)

    Time frame: RRF will be measured at weeks 2 and 4

    24h urine output

  5. Residual renal function (RRF)

    Time frame: RRF will be measured at weeks 2 and 4

    GFR (calculated during the analysis)

Study contacts

Contact information is provided by the study sponsor or research team.

Tatiana De los Ríos

CONTACT

[email protected]

+4961726092688876

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

Efficacy and Tolerability of the APD Treatment of Toddlers and Newborns With the Silencia PD Cycler

Acronym: SilenciaPAED

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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